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Clinical Study of VG161 in Subjects With Advanced Malignant Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04758897
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
CNBG-Virogin Biotech (Shanghai) Ltd.

Study Description
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Brief Summary:
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This Phase I study will be conducted in HSV-seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG161, and recommended dose of VG161 for Phase II trials.

Condition or disease Intervention/treatment Phase
Advanced Malignant Solid Tumor Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) Phase 1

Detailed Description:

The trial will be conducted in 7 dose ascending cohorts, including 3 single dose accelerated titration design pilots and 4 multiple dose escalation groups.

Descriptive statistics will be used to summarize all data.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of VG161 in Subjects With Advanced Malignant Solid Tumors
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : March 14, 2022
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm
  1. 5.0*10^7 on D1
  2. 1.0*10^8 on D1
  3. 2.0*10^8 on D1
  4. 2.0*10^8 on D1 and D2
  5. 2.0*10^8 on Days 1 to 3
  6. 2.0*10^8 on Days 1 to 4
  7. 2.0*10^8 on Days 1 to 5
 Drug: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))
Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5.
Other Name: VG161


Outcome Measures
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Primary Outcome Measures :
  1. MTD/RP2D [ Time Frame: 1 month ]
    MTD (Maximum tolerable dose) / RP2D (Recommended dose for phase II)

  2. Occurence of DLT [ Time Frame: 1 month ]
    Occurence of DLT (Dose Limiting Toxicity)

  3. Numbers of DLT [ Time Frame: 1 month ]
    Numbers of DLT (Dose Limiting Toxicity)

  4. Occurence of AE and SAE（NCI CTCAE 5.0） [ Time Frame: 7 months ]
    Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

  5. Frequency of AE and SAE（NCI CTCAE 5.0） [ Time Frame: 7 months ]
    Frequency of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）


Secondary Outcome Measures :
  1. Tmax(h) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Time to peak

  2. Cmax(copies/ugDNA) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    Maximum concentration

  3. ORR [ Time Frame: 7 months ]
    Evaluate Objective Response Rate by RECIST 1.1.

  4. DCR [ Time Frame: 7 months ]
    Evaluate Disease Control Rate by RECIST 1.1.

  5. mPFS [ Time Frame: 7 months ]
    Evaluate medium Progression Free Survival by RECIST 1.1.

  6. CD3+, CD4+, CD8+ [ Time Frame: 7 months ]
    Concentration of CD3+, CD4+, CD8+

  7. IL15 [ Time Frame: 7 months ]
    Concentration of IL15

  8. PD-L1, PD-1 [ Time Frame: 7 months ]
    Concentration of PD-L1, PD-1,

  9. Existence of Biomarkers [ Time Frame: 4 months ]
    PD-L1, Nectin2, HVEM


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females aged within 18 to 80 years.
  2. Subject with late stage carcinoma which is refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists.
  3. There is at lease one injectable tumor lesion that meet the requirements of the assigned dose level. The superficial lesions are preferred, and the deep lesions that can be injected under the guidance of B ultrasound or computed tomography (CT) scan can also be selected.
  4. Eastern Cooperative Oncology Group (ECOG) scores 0 or 1.
  5. Life expectancy is at least 3 months.
  6. Required organ function:

1) Hematology blood (no blood transfusion or colony stimulating factor treatment within 14 days): Absolute neutrophil count (ANC)≥1.5×10^9L, Platelets ( PLT)≥75×10^9L, hemoglobin (Hb)≥85g/L; 2) Liver function: Total Serum bilirubin (TBIL)≤1.5×ULN (the upper limit of the reference range), Alanine aminotransferase (ALT)≤3×ULN, aspartate aminotransferase (AST)≤3×ULN (acceptable for patients with liver metastasis or liver cancer: TBIL≤5×ULN, AST≤5×ULN, ALT≤5×ULN); 3) Renal function: Serum creatinine≤1.5×ULN, and creatinine clearance≥50 ml/min (calculated per Cockcroft-Gault formula); 4) Coagulation function: activated partial thromboplastin time (APTT)≤1.5×ULN, international standardized ratio (INR)≤1.5×ULN.

7. Subjects of childbearing potential (male and female) must agree to use a reliable contraceptive method (hormone or barrier method or abstinence) during the study and for at least 90 days following the last dose; females of childbearing potential must have a negative blood or urine pregnancy test within 7 days of study enrollment.

8. Signed written informed consent.

Exclusion Criteria:

  1. Subject in prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation.
  2. Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation.
  3. Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks of study treatment initiation.
  4. Patients who received systemic treatment with either corticosteroids ( >10 mg/ daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.
  5. Subjects with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy (except for toxicity that the investigator assessed to be no safety risk, such as alopecia.).
  6. Subjects with any uncontrolled active Central Nervous System (CNS) metastasis or meningeal metastasis with clinical symptoms.
  7. Seronegative for Herpes Simplex Virus (HSV) (HSV-1IgG and HSV-1IgM).
  8. Subjects with the relapse of HSV infection and relevant clinical manifestations, such as lip herpes, herpes keratitis, herpes dermatitis, and genital herpes.
  9. Subjects with other uncontrolled active infections.
  10. Known history of immunodeficiency and test positive of human immunodeficiency virus (HIV).
  11. Active infection of hepatitis B (HBV) (hepatitis b virus titer higher than the detection limit or those requiring antiviral therapy), or hepatitis C virus (HCV).
  12. History of severe cardiovascular disease:

1)Ventricular arrhythmias requiring clinical intervention; 2)QTc interval >480 ms; 3)Acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of III grade or above within 6 months; 4)The cardiac function grade≥II or left ventricular ejection fraction (LVEF) <50% per the New York Heart Association (NYA); 5)Uncontrolled hypertension. 13. Subjects with active or past autoimmune diseases that are likely to recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); acceptable for patients with clinically stable autoimmune thyroiditis.

14. Subjects with any prior ≥Grade 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent.

15. known to have alcohol or drug dependence. 16. Persons with mental disorders or poor compliance. 17. Pregnant or lactating women. 18. Subjects with any significant unrelated systemic illness that to the investigator's opinion would compromise the subject's eligibility to participate the study.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758897


Contacts
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Contact: Jin Li, doctor 13761222111 lijin@csco.org.cn

Locations
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China, Shanghai
ShangHai East hospital Recruiting
ShangHai, Shanghai, China
Contact: Jin Li         
Xin Hua Hospital Affiliated to ShangHai Jiao Tong University School of Medicine Recruiting
ShangHai, Shanghai, China
Contact: Wei Shen         
Sponsors and Collaborators
CNBG-Virogin Biotech (Shanghai) Ltd.
Investigators
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Principal Investigator: Jin Li, doctor Shanghai East Hospital
More Information
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Responsible Party: CNBG-Virogin Biotech (Shanghai) Ltd.
ClinicalTrials.gov Identifier: NCT04758897    
Other Study ID Numbers: VG161-C101
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CNBG-Virogin Biotech (Shanghai) Ltd.:
Solid Tumor
Additional relevant MeSH terms:
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Neoplasms